Effectiveness of Spinal Manipulation in Fibromyalgia

Effectiveness of Spinal Manipulation in Addition to Standard Pharmacological Treatment in Fibromyalgia : A Blinded Randomized Clinical Trial

The aim of this study is to evaluate whether spinal manipulation, which is a potential treatment method for musculoskeletal pain, has an additional contribution in patients with fibromyalgia receiving standard pharmacological treatment.

Although fibromyalgia (FM) is quite common, success rates in conservative treatment are unsatisfying. Combination of pharmacological and non-pharmacological applications is recommended in treatment. Although the etiology of FM is not well known, characteristic findings such as hyperalgesia and allodynia suggest problems related to pain and sensorial processing in the central nervous system.

It has been suggested that spinal manipulation can alter sensorimotor integration in the central nervous system and therefore can be used in the treatment of central sensitization syndromes. However, manual therapy applications, which were examined under the heading of chiropractic in the 2016 EULAR treatment recommendations, were not recommended due to the low quality (open-label, quasi-experimental) of the studies conducted so far. However, it has been suggested for future studies to investigate whether the combined use of pharmacological and non-pharmacological treatments is more effective than single modality management. But since then unfortunately a high level of evidence also could not be obtained related to use of spinal manipulation in FM due to reasons such as lack of reporting of the manual therapy methods used in detail, conducting studies involving mostly soft tissue techniques and not following CONSORT recommendations.

This study is planned as a prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study considering the concepts that have been lacking the literature.

Inclusion Criteria:

• Being diagnosed with fibromyalgia according to the 2016 ACR Fibromyalgia Diagnostic Criteria
• Having been receiving pharmacological treatment for fibromyalgia for at least 2 weeks
• VAS pain score> 4

Exclusion Criteria:

• Structural problem of the musculoskeletal system (acute spinal disc herniation, acute spondylolisthesis / lysis, fractures and dislocations, advanced degenerative changes, spinal stenosis)
• Pregnancy or breastfeeding
• Inflammatory or infectious disease
• Malignancy
• Neuromuscular disease
• History of spinal surgery
• Unstable psychiatric disease
• Previously received manual therapy or having enough information about manual therapy to distinguish between sham and real therapy (researched online, watched videos…).